MAUDE Adverse Event Report: MEDTRONIC IRELAND HAWKONE 6FR; CATHETER, PERIPHERAL, ATHERECTOMY

Catalog Number H1-M

Device Problem Device Operational Issue (2914)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/05/2018

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

The physician was attempting to use a hawkone directional atherectomy catheter to treat a 200mm plaque with little calcification cto (chronic total occlusion-100%) in the distal right sfa.The artery had a diameter of 5mm and was moderately tortuous.The device was prepped as per the ifu with no issues identified.The procedure used a 6 fr non-medtronic sheath and a 5mm spider fx filter guidewire.The vessel was not pre-dilated.After a couple of passes the thumbswitch of the device was not functioning and the cutter blade of the device would not retract.The cutter blade was outside the housing.Upon removal of the spider wire a foreign body was found.There was no issue with the spider wire.No damage was noted to the hawkone.Another hawkone device was used to complete the procedure.No patient injury was reported.

Manufacturer Narrative

Evaluation summary: image analysis: the customer provided an image of a black object with red material on the right edge.The black object appears to be a piece broken off from a different piece.The left edge of the black object shows a possible ductile fracture face.The red material on the tip is unknown could not be identified.The object provided in the photo was not returned with the hawkone device.The origin of the black object is unknown, it does not appear part of a component of the hawkone or the spider fx.Device analysis: the hawkone was returned for evaluation with the cutter driver connected.No other ancillary devices were included.The hawkone was inspected and the laser drill coil segment was observed to be curved approximately 45 degrees.It was discovered the distal rim of the cutter window was penetrated by the cutter.The cutter pushed through and the platinum iridium and the material flapped over.The tecothane at the cutter window rim was observed.The platinum iridium at the edge of the cutter window appeared to be penetrated/sheared.Within the laser drilled coils biological debris was observed.Within the lumen biological debris was observed.A tweezers from the lab was used to push the flap down.With the platinum iridium pushed down, it did not show any indication of component embolization.The flapped platinum iridium was also compressed.The thumb-switch was retracted and the cutter was pulled back out from the damaged area of the distal assembly.It was not able to be pulled back into the proximal end of the cutter window.The thumb-switch was advanced and the cutter moved forward approximately 1.8cm from the cutter window.A 0.014" guidewire from the lab was pushed though the cutter window through to the flush mouth.A portion of the biological debris within the laser drilled coil exited the flush mouth.No traces of the of the hawkone distal assembly were found within the removed debris.If information is provided in the future, a supplemental report will be issued.

• Brand Name: HAWKONE 6FR
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 7392773
• MDR Text Key: 104250446
• Report Number: 9612164-2018-00623
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 00643169968332
• UDI-Public: 00643169968332
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161361
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2021
• Device Catalogue Number: H1-M
• Device Lot Number: 0008979216
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/02/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 79 YR